The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Diastat Anti-thyroid Peroxidase Elisa Model #300.
| Device ID | K020687 |
| 510k Number | K020687 |
| Device Name: | DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Contact | Eileen Mccafferty |
| Correspondent | Eileen Mccafferty AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-04 |
| Decision Date | 2002-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817008559 | K020687 | 000 |
| 07340058410134 | K020687 | 000 |